Valve loader method, system, and apparatus

ABSTRACT

A valve loading system is provided that uses a valve loader to transfer a valve or other medical device from a storage cartridge into a deployment catheter. The valve or other medical device can be implanted or positioned within a patient using the catheter after the valve or other medical device has been compressed and loaded into the catheter using the valve loader. The process then can be repeated by using the valve loading system to load or introduce another valve or other medical device into the catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/798,006, filed Mar. 15, 2013, (entitled “VALVE LOADERMETHOD, SYSTEM, AND APPARATUS”) and U.S. Provisional Patent ApplicationNo. 61/785,971, filed Mar. 14, 2013, (entitled “VALVE LOADER METHOD,SYSTEM, AND APPARATUS”), the entire disclosures of which are herebyincorporated by reference. Any and all priority claims identified in theApplication Data Sheet, or any correction thereto, are herebyincorporated by reference under 37 CFR 1.57.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the invention generally relate to the field of medicaldevices, and in particular, to methods, systems, and devices for loadingor introducing into a catheter a valve or stent for implantation into abody.

2. Description of the Related Art

A catheter is a tube that can be inserted into a body, or body cavity,duct or vessel. A range of polymers are used for the construction ofcatheters, including but not limited to silicone, rubber, latex,polyurethane, Nylon, copolymers of polyurethane and polyether such asPEBAX®, and thermoplastic elastomers. Silicone is one of the most commonchoices because it is generally inert and generally not reactive to bodyfluids and a range of medical fluids with which it might come intocontact. Catheters can be used to allow for drainage or injection offluids to the body, or access into the body by surgical instrumentsand/or implantable devices. In order for a catheter to provide access tothe body, the implantable device must be inserted into the catheter.

SUMMARY

Embodiments of the invention generally relate to loader devices,systems, and methods for loading and/or introducing into a catheter avalve or other medical device for implantation into a body. In certainembodiments, the medical devices, systems, and methods allow thecatheter to be loaded or introduced with multiple valves or othermedical devices.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIG. 1 is a system view of an embodiment of a valve loading system usedfor loading and/or introducing a valve or other medical device into adeployment catheter or other deployment apparatus.

FIG. 2 is a perspective view of an embodiment of a valve loader of thesystem of FIG. 1, which valve loader is used for loading and/orintroducing a valve or other medical device into a deployment catheteror other deployment apparatus.

FIG. 3 is a sectioned view of the valve loader of FIG. 2.

FIG. 4 is an exploded perspective view of the valve loader of FIG. 2.

FIG. 5 is a further exploded perspective view of the valve loader ofFIG. 2.

FIG. 6 is a sectioned view of some of the system components of FIG. 1showing the valve loader in conjunction with an embodiment of acartridge and an embodiment of a medical device to be loaded into anembodiment of a catheter or other deployment apparatus.

FIG. 7 is a sectioned view of the valve loader within the cartridge andthe medical device of FIG. 6 loaded into the valve loader of FIG. 2.

FIG. 8 is an enlarged perspective view of the valve loader of FIG. 2with certain components removed.

FIG. 9 is a sectioned view of a plunger and a locking mechanism of thevalve loader of FIG. 2.

FIG. 10 is an enlarged sectioned partial view of the valve loader ofFIG. 2

FIG. 11 is another enlarged sectioned partial view of the valve loaderof FIG. 2

FIG. 12 is a perspective view of a cartridge used with the valve loaderof FIG. 2.

FIG. 13 is another perspective view of the cartridge of FIG. 12.

FIG. 14 is a front view of the cartridge of FIG. 12.

FIG. 15 is a further front view of the cartridge of FIG. 12 with a coverremoved.

FIG. 16 is a rear view of the cartridge of FIG. 12.

FIG. 16A is a rear view of another cartridge.

FIG. 17 is a top view of the cartridge of FIG. 12.

FIG. 18 is a bottom view of the cartridge of FIG. 12.

FIG. 19 is a left side view of the cartridge of FIG. 12.

FIG. 20 is a right side view of the cartridge of FIG. 12.

FIG. 21 is a sectioned perspective view of the cartridge of FIG. 12.

FIG. 22 is a perspective view of an embodiment of a deployment catheteror other deployment apparatus used in the system of FIG. 1.

FIG. 23 is a side view of the deployment catheter or other deploymentapparatus of FIG. 22.

FIG. 24 is an enlarged view of a distal end of the deployment catheteror other deployment apparatus of FIG. 23 taken in the circle 24 of FIG.23.

FIG. 25 is a sectioned view taken along the line 25-25 of FIG. 24showing the distal end of the deployment catheter or other deploymentapparatus of FIG. 22.

FIG. 26 is an enlarged perspective view of a control portion of thedeployment catheter or other deployment apparatus of FIG. 22.

FIG. 27 is a first section taken through the deployment catheter orother deployment apparatus of FIG. 22.

FIG. 27A is a first section view of a deployment catheter havingfrictional members.

FIG. 27B is a first section view of a deployment catheter having africtional sleeve.

FIG. 28 is a second section taken at about ninety degrees from the firstsection shown in FIG. 27.

FIGS. 29A-B are enlarged views of the distal end of an embodiment of thedeployment catheter or other deployment apparatus.

FIGS. 29C-D are enlarged views of the distal end of an embodiment of adeployment catheter before and after reflow.

FIG. 30 is an enlarged view of the distal end of an embodiment of thedeployment catheter being loaded with a device.

FIG. 31A is a view of an embodiment of the deployment catheter. FIGS. 31B-D represent sections taken at various positions along the deploymentcatheter. In FIG. 31C, the valve 500 has been removed for clarity.

FIGS. 32A-C are a sequence of illustrations depicting an embodiment ofthe deployment catheter deploying a valve into a lung passageway.

FIGS. 33A-E are enlarged views depicting embodiments of thestabilization wire tip 720.

DETAILED DESCRIPTION OF THE EMBODIMENTS

A valve loading system and related components will now be described withreference to the accompanying figures of one or more embodiments. Theterminology used in the description presented herein is not intended tobe interpreted in any limited or restrictive manner. Rather, theterminology is simply being utilized in conjunction with a detaileddescription of embodiments of the systems, methods and relatedcomponents. Furthermore, embodiments may comprise several novelfeatures, no single one of which is solely responsible for its desirableattributes or is believed to be essential to practicing the inventionsherein described.

The terms “valve,” “deployable medical device,” and “medical device” asused herein are broad interchangeable terms and, unless otherwiseindicated, the terms can include within their meanings, withoutlimitation, stents, valves, lung reduction valves, coils, filters,embolic protection devices, balloons, augmentation devices, probes,anchors, sponges, or any other medical device, deployable or otherwise,that is configured to be loaded or introduced into a catheter or otherdeployment apparatus. In certain embodiments, the valve and/or medicaldevice is the type disclosed in U.S. Pat. No. 6,293,951 or in U.S.Patent Application Publication No. 2003-0050648, each of which is herebyincorporated in its entirety.

In certain embodiments, the valve loading system described herein can beconfigured to load valves or medical devices as small as about 5 mm, 6mm, 7 mm, and 9 mm in diameter. The valve loading system, in certainembodiments, can be configured to compress or collapse valves or medicaldevices for deployment using a bronchoscope comprising a working channeldiameter of about 2.0 mm or greater, for example, about 2.6 mm. Incertain embodiments, the valve or medical device comprises a radiopaquematerial that is visible through a deployment catheter or otherdeployment apparatus, bronchoscope, or body.

The terms “body” and “patient” as used herein are broad interchangeableterms that generally refer to mammalian (human or animal) bodies,patients, organs, lumens, cavities, vessels, passageways, channels, orthe like.

As discussed above, a valve or other medical device, deployable orotherwise, can be introduced into a catheter or other deploymentapparatus using methods, systems, and devices described herein. In someembodiments, a valve loading system is provided that generallycomprises, without limitation, a deployment catheter or other deploymentapparatus, a valve loader, a valve-carrying cartridge (also referred toherein as a interchangeable medical device cartridge), and/or othercomponents. The valve or other medical device can be implanted orpositioned within a patient using the catheter or other deploymentapparatus after the valve or other medical device has been loaded intothe catheter or other deployment apparatus using the valve loader. Insome embodiments, the process then can be repeated by using the valveloading system to load or introduce another valve or other medicaldevice into the catheter (as used herein, the term “catheter” includeswithout limitation any other deployment apparatus).

FIG. 1 illustrates an embodiment of a valve loading system 100 that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention. The illustrated valve loadingsystem 100 generally comprises, among other components, a deploymentcatheter 102, a cartridge 104, and a valve loader 106. The cartridge 104carries, transports, and/or stores a valve or other medical device. Insome configurations, the cartridge 104 is designed to store the valve orother medical device for limited or more extended periods of time. Insome embodiments, the cartridge 104 is interchangeable with othercartridges. The valve loader can comprise a first open cavity 214 thataccommodates the cartridge 104. With the cartridge 104 positioned in thecavity 214 and with a distal end 112 of the deployment catheter 104positioned in a connection port 108, the valve or other medical devicecan be transferred from the cartridge 104 into the deployment catheter102 using the valve loader 106. Thus, the illustrated valve loader 106can be configured to provide sterile loading of the valve or othermedical device into the deployment catheter 102.

The illustrated valve loader 106 comprises an outer housing structure202. In some embodiments, the outer housing structure 202 is constructedof plastic, metal, or other like material. Preferably, the outer housingstructure 202 is sized and configured for holding in a hand. In someembodiments, the outer housing structure 202 can have a length thateasily allows for placement in a user's hand. For example, the outerhousing structure 202 can be 5, 6, 7, or 8 inches in length, which willeasily fit within a user's hand. The outer housing structure 202 cancomprise a generally cylindrical shape or other suitable form to enhancethe ergonomics and to provide for easy placement in or control by ahuman hand. In the illustrated configuration, the outer housingstructure 202 comprises a flattened cylindrical shape. Other structures,materials, shapes, and sizes also are possible.

As illustrated in FIG. 1 and FIG. 2, the housing structure 202 can havea top side 204, a bottom side 206, a proximal end 208, and a distal end210. Any directional terms used herein are merely to provide a frame ofreference and should not be considered to limit the scope of the claimedinvention. As used herein, “distal” means toward the location in whichthe valve or other medical device will be deployed while “proximal”means toward the user of the component (e.g., toward the user of thevalve loader 106).

The outer housing structure 202 preferably features a plurality ofrecesses 212 along the top and bottom sides 204, 206. The illustratedouter housing structure 202 comprises two recesses 212 along the topside 204 and four recesses 212 along the bottom side 206. In someembodiments, the two recesses 212 along the top side 204 are generallyaligned with two of the four recesses 212 along the bottom side 206.Preferably, the two recesses 212 are positioned on opposite ends of thetop side 204. More preferably, the two recesses 212 on the top side 204are positioned with one of the two recesses 212 on each side of a firstopen cavity 214.

The first open cavity 214 can have any suitable configuration. In someembodiments, the first open cavity 214 comprises a substantiallyrectangular shape with an angled portion 216; however, other shapes anddimensions are possible. In certain embodiments, the shape andconfiguration of the first open cavity 214 corresponds to the outershape and configuration of the cartridge 104 such that the cartridge 104can be inserted into the first open cavity 214 in only one direction,orientation or position. In other words, the cavity 214 of the housing202 can comprise a first shape and the cartridge 104 can comprise acomplementary shape such that, when inserted into or coupled with thehousing 202, the cartridge 104 is properly oriented for its intendeduse.

With reference to FIG. 1 and FIG. 2, the housing structure 202 cancomprise the connection port 108 that is defined in part by a secondopen cavity 218 that can receive a distal end 112 of the deploymentcatheter 102 or another device, for example, a shipping lock 114. Insome embodiments, the proximal end of the shipping lock 114 can beshaped and configured to closely correspond to the shape andconfiguration of the distal end 112 of the deployment catheter 102.While the illustrated housing structure 202 comprises the second opencavity 218, which comprises a funnel-type configuration that helps toreceive the distal end 112 of the deployment catheter 102, the housingstructure 202 can comprise a generally flat distal end 210 or aprotruding distal end 210.

The housing structure 202 of the valve loader 106 can be constructed oftwo halves or sides 202A, 202B that are secured together in any suitablemanner. In some configurations, the two portions 202A, 202B snaptogether and can be secured together with posts or the like. Preferably,one of the two portions 202B is considered a male portion while theother one of the two portions 202A is considered a female portion andthe male and female portions can be joined together in any suitablemanner.

In certain embodiments and as shown best in FIG. 3 and FIG. 4, thehousing structure 202 defines one or more inner chambers that contain aplurality of components, including but not limited to a loader plunger220 (also referred to herein as an actuator), a cartridge lockingmechanism 222, an alignment insert 224, an alignment tube 226, and afirst and a second grip pawl 228A, 228B.

With reference to FIGS. 4 and 5, the loader plunger or actuator 220 isconfigured to slide within and along an axial center of the illustratedhousing structure 202. In certain embodiments, the loader plunger oractuator 220 is configured to be screwed or rotated into and along anaxial center of the housing structure 202. In certain embodiments, thehousing structure 202 comprises a stop to signal or indicate to the userwhen the plunger or actuator 220 has traveled to the correct position inthe housing for completely loading the valve or medical device into thedeployment catheter or deployment apparatus. In certain embodiments, thecartridge 104 comprises a cover, cap, or lid 422 having a thicker tab431 to act as a stop or signal or indication to the user when theplunger or actuator 220 has traveled to the correct position in thehousing for completely loading the valve or medical device into thedeployment catheter or deployment apparatus. In certain embodiments, thethicker tab 431 is changes length, shape, and/or size to determine howfar the plunger or actuator 220 can travel into the housing therebyaffecting the position of the valve or medical device within thedeployment catheter or deployment apparatus. In certain embodiments, thecover, cap, or lid 422 can be positioned flushed with the outer surfaceof the cartridge 104 or the cover, cap, or lid 422 can be positioned (atdifferent depths) inset from the outer surface of the cartridge 104 todetermine how far the plunger or actuator 220 can travel into thehousing thereby affecting the position of the valve or medical devicewithin the deployment catheter or deployment apparatus. In certainembodiments, the cartridge 104 comprises a cover, cap, or lid 422 havinga tooth or thinner tab 430 that provides an audible indication that theplunger or actuator 220 has traveled to the correct position in thehousing for completely loading the valve or medical device into thedeployment catheter or deployment apparatus. As shown in FIG. 5, theloader plunger or actuator 220 can have an axial groove 230 that extendsalong at least a portion of the loader plunger 220. The axial groove 230preferably terminates proximally of the distal end of the loader plunger220. The distal end of the axial groove 230 preferably terminates withina further groove 232 (see FIG. 4) that extends diagonally across theaxial groove 230.

As illustrated in FIGS. 4, 5 and 6, the cartridge locking mechanism 222(also referred to herein as a safety apparatus) can be positioned withinthe housing structure 202. The illustrated cartridge locking mechanism222 comprises a generally “U” shaped configuration or the likecomprising a first end 234 and a second end. The first end 234 of theillustrated cartridge locking mechanism 222 is supported by and/orcoupled to a pivot pin 236, and the balance of locking mechanism 222 isallowed to rotate or swing or move thereabout.

As shown in FIG. 5 and FIG. 9, the locking mechanism 222 comprises afirst nub 238 and a second nub 240 that, in the illustratedconfiguration, face the male half 202A of the illustrated outer housing202. The first nub 238 is slightly larger than the second nub 240 andthe first nub 238 has a shape and orientation that generally correspondsto the shape and orientation of the groove 232. The first nub 238 isseparated from the second nub 240 by a distance that can accommodate atleast one of the surfaces that extends axially alongside the axialgroove 230. In addition, the second nub 240 is sized such that it can bereceived within the axial groove 230 while the first nub 238 is sizedsuch that it cannot be received within the axial groove 230.

Thus, as the loader plunger 220 is pushed into the housing structure202, the locking mechanism 222 rotates slightly as the first nub 238moves within the generally diagonal groove 232 until the second nub 240is aligned with the axial groove 230. When the locking mechanism 222 hasrotated and the second nub 240 is aligned with the axial groove 230,further pushing of the loader plunger 220 into the housing structure 202causes the loader plunger 220 to move distally with the second nub 240moving axially along the axial groove 232. During this continuedmovement, the locking mechanism is secured against rotation due to thepositioning of the second nub 240 within the axial groove 230.

Similarly, as the loader plunger is withdrawn from the housing structure202, the axial groove 230 moves relative to the second nub 240 until thesecond nub 240 reaches the diagonal groove 232. When the second nub 240reaches the diagonal groove 232, the second nub 240 slides within thediagonal groove, which causes rotation of the locking mechanism 222. Therotation of the locking mechanism 222 draws the first nub 238 into thediagonal groove 232. The first nub 238 stops further withdrawal of theloader plunger 220 from the outer housing structure 202 after the firstnub 238 is positioned within the diagonal groove 232.

With reference to FIG. 8, the locking mechanism 222 also comprises afirst stop 242 and a second stop 244. The rotational movement of thelocking mechanism 222 is limited in the illustrated configuration by thefirst stop 242 and the second stop 244. The first stop 242 moves intoabutment with a first surface 246 of the housing structure 202 duringrotation in a first direction (i.e., upward or clockwise rotation) andthe second stop 244 moves into abutment with a second surface 248 of thehousing structure 202 during rotation in a second direction (i.e.,downward or counterclockwise rotation). Other configurations also can beused to limit the range of rotational movement of the locking mechanism222.

As described above, the illustrated locking mechanism 222 also comprisesa second end 250. The second end extends through an opening 252 thatopens into the first open cavity 214. The second end 250 of thecartridge locking mechanism 222 acts as an arm, or a bracket, or a barthat secures the cartridge 104 into the first open cavity 214 of thehousing structure 202, or that reduces the likelihood of the cartridge104 being inserted into the first open cavity 214 without the loaderplunger 220 being fully retracted from the housing structure 202. Inthis manner, the locking mechanism 222 safeguards the plunger 220against damage that can be caused by insertion or removal of thecartridge 104 without the plunger 220 being fully retracted from thefirst open cavity 214 or the cartridge 104. As the locking mechanism 222rotates, swings, or moves toward the first open cavity 214 of thehousing structure 202, the arm, bracket, or bar of the second end 250enters or moves into the first open cavity 214 of the housing structure202 through the opening 252. If the cartridge 104 is within the firstopen cavity 214, then the arm, bracket, or bar of the second end 250 canengage with or otherwise lock the cartridge 104 into the first opencavity 214. As the loader plunger 220 is pulled out of the housingstructure 202, the cartridge locking mechanism 222 rotates, swings, ormoves the cartridge locking mechanism 222 away from the first opencavity 214 of the housing structure 202, thereby allowing the arm,bracket, or bar of the second end 250 to be removed or substantiallyremoved from the first open cavity 214 of the housing structure 202 andto unlock or disengage the cartridge 104 if the cartridge is presentwithin the first open cavity 214.

With reference to FIG. 10 and FIG. 11, the alignment insert 224generally defines a passageway 252. At least a portion of the passageway252 reduces in diameter from a proximal end of the portion to a distalend of the portion. The diameter(s) of the passageway 252 and/orportions thereof can vary. For example, alignment inserts 224 withlarger inner diameters can be used for applications wherein largermedical devices are loaded using the loader 106. In some embodiments,the inner surface of the passageway 252 is textured and/or coated with alubricous material (e.g., PTFE) to reduce the frictional interactionbetween the medical device and the passageway 252. In some embodiments,the diameter decreases from a proximal end of the alignment insert 224to a location partway through the alignment insert 224. Otherconfigurations are possible.

While the outer structure of the alignment insert 224 can have anysuitable configuration, the illustrated configuration comprises agenerally cylindrical proximal end 254 and a smaller diameter generallycylindrical proximal end 256. Preferably, the proximal end 254 of thealignment insert 224 is located such that its proximal end surface isgenerally flush with a surrounding or adjacent surface of the first opencavity 214.

The alignment insert 224 can be positioned in the housing structure 202,and can be configured to guide and/or compress the valve or medicaldevice 500 into a compressed state for insertion or positioning into thedeployment catheter 102. The alignment insert 224 can be constructed ofplastic, metal, or other similar material. In the illustratedconfiguration, the proximal end 254 comprises two or more tabs 258. Thetabs 258 can be positioned within recesses formed in the outer housing202. Thus, the tabs 258 can help to properly locate the alignment insert224 within the outer housing 202 and to limit axial movement of thealignment insert 224 relative to the outer housing 202.

The passage 252 defined by the alignment insert 224 preferably isaxially aligned with a passage 260 defined by the alignment tube 226.The passage 260 comprises a proximal generally cylindrical portion 262,a tapering portion or funnel-shaped channel 264, a smaller diametergenerally cylindrical portion 266, another slightly larger diametergenerally cylindrical portion 268 and a slightly expanding portion 270.The passage further comprises a generally cylindrical distal portion 272and a distal portion 274 that is generally conical in configuration. Theinner diameter of portions of the passage 260 can vary depending on thesize of the medical device with which the loader 106 is designed to beused. In some embodiments, the interior surface of the passage 260 istextured and/or coated with a lubricous material to reduce frictionbetween the surface of the passage 260 and a medical device within thepassage 260.

The smaller diameter portion 266 preferably is smaller than the outerdiameter of the catheter that the loader 106 is designed to be used withwhile the slightly larger diameter portion 268 is slightly larger thanthe same outer diameter. Accordingly, during insertion, the distal endof the deployment catheter 102 can abut against the step defined betweenthese two portions 266, 268.

The generally cylindrical proximal portion 262 of the alignment tube 226preferably is sized and configured to receive the distal end 256 of thealignment insert 224. As shown, the distally facing surface of theproximal end 254 of the alignment insert 224 can comprise a shallowchannel 276 and the proximally facing proximal surface of a proximal endof the alignment tube 226 can be provided with a somewhat deeper channel278.

A spring 280 or the like can be positioned within a proximal end withinthe shallow channel 276 of the alignment insert 224 and with a distalend within the deeper channel 278 of the alignment tube 226. The spring280 or other biasing member advantageously biases apart the alignmentinsert 224 and the alignment tube 226. Because the alignment insert 224is generally axially fixed relative to the outer housing 202 by the tabs258, the alignment tube 226 is capable of axial movement relative to theouter housing 202 and can be biased by the spring 280 toward a firstposition, which can be defined by a feature of the surrounding portionof the outer housing 202.

The alignment tube 226 can constructed of plastic, metal, or othersimilar material. In certain embodiments, the alignment tube 226 has agenerally rectangular outer shape (however, other shapes andconfigurations are possible without deviating from the spirit of theembodiment).

The alignment tube 226 preferably has an opening 282. The illustratedopening 282 is generally vertical. Preferably, the opening 282 extendsthrough a central portion of the illustrated alignment tube 226. Theopening 282 is configured to receive the first grip pawl 228A and thesecond grip pawl 228B, one on either side of the opening 282. In certainembodiments, the opening 282 has a rectangular shape but other shapesand configurations are possible as well. The alignment tube 226 alsopreferably comprises a first and a second external post 284. The post284 extends laterally outward from the lateral surfaces of the alignmenttube 226. Preferably, the position of the posts 284 are to each lateralside of the opening 282 such that the axial location of the posts 284are between the proximal and distal ends of opening 282. Otherconfigurations are possible.

The first and second grip pawls 228A, 228B preferably are constructed ofplastic, rubber, polymer, or other similar material. The first grip pawl228A can be positioned generally above the alignment tube 226 while thesecond grip pawl 228B can be positioned generally below the alignmenttube 226. The grip pawls 228A, 228B each can comprise a first end 286A,286B supported and/or coupled to a respective pivot pin 288A, 288B thatis connected to the housing structure 202. Thus, the grip pawls 228A,228B are allowed to swing or rotate about the pivot pins 288A, 288B. Thegrip pawls 228A, 228B each can also have a second end 290A, 290B.

Each second end 290A, 290B in the illustrated configuration comprises agripping portion 292A, 292B and a surrounding portion 294A, 294B. Thegripping portions 292A, 292B can be configured to be at least partiallyinserted into the opening 282 in the alignment tube 226, and thesurrounding portions 294A, 294B can be configured to be at leastpartially wrapped around the outer surface of the alignment tube 226.More preferably, the surrounding portions 294A, 294B abut against theposts 284 of the alignment tube 226. Even more preferably, mountingrecesses 296A, 296B formed in the surrounding portions 294A, 294B abutagainst the posts 284 of the alignment tube 226 and the mountingrecesses 296A, 296B are offset in the distal direction relative to therotational axes defined by the pins 288A, 288B. The slight offset in thelocation of the recesses 296A, 296B relative to the rotational axesdefined by the pins 288A, 288B cause the alignment tube 226 to snap intothe first position following any slight displacement in the proximaldirection.

In a default or normal position, the grip pawls 228A, 228B can besubstantially perpendicular to the alignment tube 226. With the secondends 290A, 290B of the first and second grip pawls 228A, 228B positionedin the alignment tube 226, there is a first gripping portion 300A and asecond gripping portion 300B that come together and form a generallycylindrical or tubular area or clamp that is configured to hold, clamp,retain, lock, and/or grip the deployment catheter 102 within thealignment tube 226.

The first and second gripping portions 300A, 300B comprise peaks, sharpfeatures or ribs 302. As shown, the ribs 302 preferably are configuredto define a larger inner diameter at the proximal and distal ends and asmaller inner diameter in the middle. Thus, as the grip pawls 228A, 228Brotate in the proximal direction, the diameter defined by the ribs thatare generally normal to each other is greater than the diameter definedby the ribs in the middle that are generally normal to each other whenthe grip pawls 228A, 228B rotate back toward the starting position(i.e., corresponding to the first position of the insert tube 226).Thus, in the starting position, the center ribs of the ribs 302cooperate to retain the end of the deployment catheter while, oncerotated from the starting position in the proximal direction, the largerribs cooperate together and define a larger diameter such that thedeployment catheter can be inserted or removed from the grip pawls 228A,228B.

In some configurations, one or more of the grip pawls 228A, 228B abutsagainst at least a portion of a release mechanism 304. The illustratedrelease mechanism 304 comprises a leaf spring 306. A first portion 308of the leaf spring 306 is supported by and/or coupled to a pivot pin 310and the leaf spring 306 is allowed to at least partially rotate aboutthe pivot pin 310. The first portion 308 of the leaf spring 306comprises a cantilever portion 312 that can be engaged with a button314. The leaf spring 306 comprises a second portion 316 that can beconfigured to rest at least partially on an inner structure of the outerhousing 202, the alignment tube 226 or the like. The first portion 308and the second portion 316 can be joined at a proximal end and canextend at an angle relative to each other. In addition, the firstportion 308 preferably is more rigid (e.g., has a greater thickness toresist bending) than the second portion 310. Rotation of the firstportion 308 about the pivot pin 310 causes flexure of the second portion316 such that the second portion 316 acts to resist rotation of thefirst portion 308 about the pivot pin 310. More preferably, the secondportion 316 biases the first portion 308 to a starting position if thecantilever portion 312 is moved downward in the illustratedconfiguration by the button 314.

As illustrated in FIGS. 10 and 11, the leaf spring 306, in certainembodiments, comprises a cam portion 318 that is engaged with the grippawl 228A. In certain embodiments, the grip pawl 228A, 228B comprises aledge, lip, groove, or cavity 320 that can be engaged by the cam portion318 of the leaf spring 306 when the cam portion 318 slides upward alongthe side of the grip pawl 228A a sufficient distance. Thus, the camportion 318 of the grip pawl 228A can be locked into the deflectedposition until a proximally directed force is provided to the alignmenttube 226. The leaf spring 308 can make a distinct clicking sound orother audible sound when snapping into position on the ledge of the grippawl 228A.

As discussed above, when the button 314 is pressed into the housingstructure 202, the button 314 applies a force on the cantilever portion312 thereby causing the leaf spring 306 to rotate, pivot or swing aboutthe pivot pin 310. The movement of the cantilever portion 312, andtherefore the first portion 308, of the leaf spring 306 causes the camportion 318 to rotate, which causes the cam portion 318 to effectivelyslide along a portion of the grip pawl 228A and snap into positionalongside the grip pawl 228A. The interaction between the cam portion318 and the grip pawl 228A causes the grip pawl 228A to rotate away fromthe pivot pin 310. The movement of the grip pawl 228A causes movement ofthe alignment tube 226 in the proximal direction due to the interfacebetween the mounting recesses 296A, 296B and the posts 284. The movementof the alignment tube 226 results in rotation of both of the grip pawls228A, 228B and the grip on any catheter previously secured within thealignment tube 226 is released such that the catheter can be removed.

Preferably, the cam portion 318 remains in contact with the surface ofthe grip pawl 228A until a subsequent catheter insertion occurs. In theillustrated embodiment, the slight step 320 is provided onto which aportion of the cam portion 318 rests. The movement of the cam portion318 over the edge of the step 320 results in a sound that indicates theunclamping of the catheter for removal. A subsequent insertion of acatheter drives the alignment tube 226 further in the proximaldirection, which allows cam portion 318 of the leaf spring to drop offof the step 320 and to snap back to its original position with anaccompanying sound that indicates that clamping of the catheter hasoccurred.

The button 314 can be constructed of plastic, metal or other suitablematerial and the button 314 can be moveably positioned within thehousing structure 202. In certain embodiments, the button 314 is coupledto, connected to or engaged by a spring or other biasing element 322that applies a force to push the button 314 towards the outer surface ofthe top side 204 of the housing structure 202, which is the normalposition for the button 314. The button 314 comprises a lip or ledge 324that can be configured to prevent the button 314 from being forcedentirely out of the housing structure 202 by the spring or biasingelement 322. The spring or biasing element 322 can be mounted over astem 323 of the button 314. When the button 314 is pressed into thehousing structure 202, the button 314 moves toward a second position inwhich the spring 322 is compressed. In the second position, the button314 engages and/or applies a force on the cantilever portion 312 of theleaf spring 306, thereby causing the cam portion 318 of the leaf spring306 to engage the first grip pawl 228A to release the deploymentcatheter 102. In certain embodiments, the button 314 engages and/orapplies a force on the cantilever portion 312 of the leaf spring 306,thereby causing the cam portion 318 of the leaf spring 306 to engage thefirst grip pawl 228A to move or rotate the first grip pawl 228A towardsthe proximal end thereby causing the release the deployment catheter102. In certain embodiments, the first and second grip pawls 228A, 228Bare coupled (for example, due to their connection to the alignment tube226), and accordingly, when the first grip pawl 228A is moved or rotatedby the leaf spring 306 toward the proximal end, both the first andsecond grip pawls 228A, 228B move or rotate in concert toward theproximal end thereby releasing their grip on the deployment catheter102.

In certain embodiments, the button 314 is also coupled and/or engagedwith a safety slide mechanism 326 as illustrated in FIGS. 10 and 11. Thesafety slide mechanism 326 can be configured to reduce or eliminate thelikelihood of the button 314 being pushed into the housing structure 202unless such a movement is desired. The safety slide mechanism 326 can beconstructed of plastic, metal, or other like material. The safety slidemechanism 326 comprises a proximal end 328 and a distal end 330. Incertain embodiments, the proximal end 328 comprises a cavity or groove332 that can be configured to engage or receive the lip or ledge 324 ofthe button 314. In other words, when the slide mechanism is in aproximal position, the rim, ridge, lip or ledge 324 of the button 314 ispositioned within the cavity or groove 332 of the slide mechanism 326and, therefore, the slide mechanism 326 reduces the likelihood ofunintended depression of the button 314.

The distal end 330 of the safety slide mechanism 326 is coupled to,connected with, in contact with or engaged with a spring or otherbiasing element 336 that applies a force to push the safety slidemechanism 326 towards the button 314 to engage the lip or ledge 324 ofthe button 314 with the cavity or groove 332 of the safety slidemechanism 326. In some configurations, the safety slide mechanism 326comprises a recess that receives at least a portion of the spring orother biasing element 336. When the safety slide mechanism is moved orslid distally toward a second position, the safety slide mechanism 326releases, disengages, and/or allows the button 314 to be pressed intothe housing structure 202.

Thus, to remove or unlock or release the distal end of the deploymentcatheter 102 from the alignment tube, a two-step unlocking process isused in certain embodiments. In order to unlock the deployment catheter102, the user first slides the safety slide mechanism 326 toward thedistal end and the user then pushes the button 314 into the housingstructure 202 in order to unlock and pull out the deployment catheter102 from the housing structure 202. The two step unlocking processreduces or eliminates the possibility of breaking the deploymentcatheter 102 while positioning the valve 500 into the deploymentcatheter 102. Additionally, the two step unlocking process reduces oreliminates the possibility of removing the deployment catheter 102before the valve 500 has been properly positioned within the deploymentcatheter 102.

Cartridge

The cartridge 104 can have any suitable size, shape or configuration. Inthe illustrated embodiment, the cartridge 104 is sized, shaped andconfigured to be received within the first open cavity 214. Morepreferably, the cartridge 104 is sized, shaped and configured to bereceived within the first open cavity 214 in only one orientation.

The illustrated cartridge 104, as shown in FIGS. 12-21, generallycomprises a proximal wall 400 and a distal wall 402. A first side wall404 and a second side wall 406 generally extend between the proximalwall 400 and the distal wall 402. The illustrated cartridge alsocomprises a top wall 408 that, for aesthetic reasons, can correlate inshape and configuration (for example, a mating shape) to the outerhousing 202 of the valve loader 106. The term “wall” should not beconstrued narrowly to mean any single surface or member but rathershould be construed broadly and a wall can be comprised of multiplesurfaces that are not in a single plane but that, in cooperation withone another, form a general boundary. The illustrated cartridge 104therefore comprises a generally rectangular box shape with a rounded topwall. Other configurations and shapes, for example, circular,cylindrical square, triangular, cone, trapezoidal, elliptical, or acombination thereof, also are possible.

The cartridge 104 can be formed in any suitable manner and of anysuitable material. In some embodiments, the majority of the cartridge104 is molded of plastic or metal or another suitable material.

The cartridge 104 preferably defines at least one passage 410 thatextends in a proximal to distal direction. In some embodiments, thepassage 410 extends from the proximal wall 400 to the distal wall 402.Preferably, the passage 410 comprises a first tapering portion ortapered lumen 412 that tapers from proximal to distal, a generallycylindrical portion 414 and a second tapering portion 416 that alsotapers from proximal to distal. Thus, the passage 410 extends from aproximal opening 418 to a distal opening 420 and the proximal opening418 is larger than the distal opening 420. Other configurations arepossible but the passage 410 preferably generally reduces in diameterfrom the proximal opening 418 to the distal opening 420. In someembodiments, portions of or the entire interior of the passage 410include a roughened or otherwise textured surface. Texturing theinterior of the passage 410 can reduce the friction between the medicaldevice 500 and the interior of the passage 410. Reducing the frictionbetween the medical device 500 and the interior of the passage 410 canreduce, minimize, or eliminate the possibility that the medical device500 sticks to the interior surface of the passage 410 during storageand/or deployment of the medical device 500 from the cartridge 104. Insome embodiments, the interior surface of the passage 410 can be coated,molded, and/or bonded with a low-friction material (e.g., a lubriciousmaterial).

The proximal opening 418 preferably is generally closeable using acover, cap or lid 422. The cover 422 is shown in FIG. 14 and is shownremoved in FIG. 15. The cover 422 can have any suitable configuration.In the illustrated embodiment, the cover 422 is generally transparent ortranslucent and is formed of a plastic material. The illustrated cover422 snaps into place on the cartridge 104 but other configurations arepossible. The illustrated cover 422 comprises two lower legs 424 and oneupper leg 426 that snap into corresponding openings formed within thecartridge 104. As illustrated in FIG. 16A, the upper leg 426 can includea first flange 426 a and a second flange 426 b on the tip of the upperleg 426. The flanges 426 a, 426 b can be tapered to promote deflectionof the upper leg 426 as it is inserted into an upper leg opening 427 ofthe cartridge 104. The upper leg 426 can be configured to “snap” backinto an undeflected position when the flanges 426 a, 426 b pass throughthe upper leg opening 427. The first flange 426 a can extend upward(e.g., toward the top wall 408) from the tip of the upper leg 426 toengage with a back wall of the cartridge 104 adjacent the upper legopening 427. The second flange 426 a can extend laterally (e.g., towardone of the locking protrusions 438) from the tip of the upper leg 426 toengage with a back wall of the cartridge 104 adjacent the upper legopening 427. Engagement of the first and/or second flanges 426 a, 426 bwith a back wall of the cartridge can reduce or eliminate the likelihoodthat the cover 422 will inadvertently disconnect from the cartridge 104.In some embodiments, such engagement can necessitate both lateral andvertical deflection of the upper leg 426 to disengage the flanges 426 a,426 b to remove the cover 422 from the cartridge 104.

The cover 422 preferably defines an opening 428. The opening 428 canhave any suitable size and configuration. In the illustrated embodiment,the size and shape of the opening 428 generally correlates to across-sectional configuration of the plunger 220. In addition, a toothor thinner tab 430 extends upward into the illustrated opening 428. Thetooth 430 preferably is deflectable. The plunger 220 is received withinthe opening 428 during use and the tooth 430 snaps into position over arib formed on the plunger. The tooth 430, therefore, acts to indicatewhen the plunger 220 is fully depressed and the tooth 430 also maintainsthe fully depressed position of the plunger 220 until the plunger 220 isacted upon by a sufficient force to retract the plunger 220 in aproximal direction.

The at least one passage 410 preferably is configured to receive andstore a valve or other medical device 500. The cover 422 is configuredto reduce or eliminate the likelihood of the valve or medical device 500being removed from the cartridge 104 while the valve or medical device500 is intended to be stored in the cartridge 104. As shown, the medicaldevice 500 can comprise multiple anchors 502. The anchors 502 can definea diameter. Preferably, the proximal opening 418, between the cover 422and the first tapering portion 412, comprises a counterbore 432 that hasan outer diameter larger than the diameter defined by the anchors 502and an inner diameter that is slightly smaller than the diameter definedby the anchors 502. Thus, the anchors 502 can be captured between thedistal wall of the counterbore 432 and the cover 422.

In certain embodiments, the passage 410 can be configured to receiveand/or store more than one valve or medical device 500 that are of thesame or different size, shape, or type. Preferably, different cartridges104 comprise different colors, symbols, numbers, and/or other uniqueidentifiers to indicate that different size valves or medical devices500 are stored within the cartridges 104. In some configurations, thecartridges 104 can use other identifying indicial (e.g., numbers,colors, letters, patterns, etc.) to indicate differing medical devices,including whether different pharmaceuticals, coatings, or the like areused.

In certain embodiments, the cartridge 104 can comprise multiple passages410 or chambers for storing multiple valves or medical devices 500, andthe multiple hollow centers or chambers can be coupled to a daisy wheelor other revolver within the cartridge 104 such that the daisy wheel orother revolver can be rotated or otherwise moved e.g., raised orlowered) by the user so as to allow multiple valves 500 to be loadedinto the deployment catheter 102.

The cartridge 104 preferably also comprises at least one release tab434. The release tab 434 is joined to the cartridge at a base and can beintegrally formed with the cartridge 104. In the illustrated embodiment,each of the two lateral sides has a release tab 434. The end of eachrelease tab 434 comprises a finger pad 436 and, just below the fingerpad 436, a locking protrusion 438. The locking protrusion 438 engages acorresponding structure on the valve loader 106 to lock the cartridge104 into the first open cavity 214 of the housing structure 202. Whenthe finger pads 436 of the two release tabs 434 are squeezed toward eachother, the locking protrusions 438 separate from the structure of thehousing 202 and the cartridge 104 is released from the first open cavity214 of the housing structure 202. In one embodiment, the release tabs434 are integrally formed with the cartridge 104 and are constructed ofplastic, polymer, or other suitable material. Other lockingconfigurations also can be used.

The proximal wall 400 of the cartridge 104 can comprise at least onegroove region or recess 440 that receives the arm, bracket, or bar ofthe second end 250 of the cartridge locking mechanism 222. Thus, whenthe second end 250 extends into the first open cavity 214, the secondend 250 engages with the groove region 440 of the cartridge 104.

Deployment Catheter

It will be appreciated that any kind of deployment catheter 102 can beused with the valve loader 106, and that the following description ofthe illustrated deployment catheter 102 is intended to be generallyillustrative only and not limiting.

With reference to FIG. 22, the deployment catheter 102 has a proximalend 700 and a distal end 702. A control portion 704 is located at theproximal end 700 and a delivery portion 706 is located at the distal end702.

With reference to FIGS. 22-25, a catheter shaft 710 extends fromproximal end to distal end. The catheter shaft 710 can be configured tobe inserted into a bronchoscope or the body. Preferably, the cathetershaft 710 comprises an internal lumen 712 and a distally-located cavity714. The internal lumen 712 can have a distal end that is incommunication with the cavity 714. In some embodiments, the lumen 712 ofthe catheter shaft 710 can have a coating, for example, Teflon, or alining, for example, a polytetrafluoroethylene (PTFE) liner, or somecombination of the two. Other configurations are possible. In someembodiments, an interior surface of the cavity 714 is coated with a lowfriction (e.g., lubricious) coating. Such coating could include, forexample, PTFE. In some embodiments, a PTFE lining is attached to theinterior surface of the cavity 714. For example, a portion of a PTFEtube can be etched along its outer surface. The PTFE tube can beattached to the interior surface of the cavity 714 via, for example, areflow process. Lining the interior surface of the cavity 714 with alubricious coating or material can reduce or eliminate the likelihoodthat a medical device stored in the cavity 714 will stick to theinterior surface of the cavity. The use of a PTFE liner can increase thedetectability of the catheter 102 due to the etching of the outersurface of the PTFE tube (e.g., an amber color caused by a sodium etchprocess).

The catheter shaft 710 can be constructed of plastic, metal, polymer,rubber, nylon, other flexible materials, or a combination thereof. Incertain embodiments, the catheter shaft 710 is constructed of a flexiblepolymer extrusion, for example, PEBAX® or nylon. In certain embodiments,the catheter shaft 710 may have different regions comprising a differentdurometer level. For example, a majority of the proximal end of thecatheter shaft 710 may have a harder durometer that prevents elongation,whereas the distal end of the catheter shaft 710 may have a softerdurometer for increased flexibility. In some configurations, thecatheter shaft 710 can comprise various fillers or components, forexample, colorants for color, barium sulfate for radiopaqueapplications, and Teflon for lubricity.

In some embodiments, the catheter shaft 710 can be constructed of abraided metallic material (e.g., stainless steel) overlaid with aflexible polymer. In some embodiments, the catheter shaft 710 isconstructed from a braided polymer overlaid with a flexible polymer.Reinforcing the catheter shaft 710 with a metallic or polymer braid canreduce or eliminate variations in the length and/or diameters of thecatheter shafts 710 during and/or after manufacture. In someembodiments, reinforcing the catheter shaft 710 with a metallic orpolymer braid reduces the axial (e.g., parallel to the length of thecatheter shaft 710) compressibility of the catheter shaft 710.Preferably, the braided reinforcement reduces compressibility of thecatheter shaft 710 in the axial direction without substantially reducingthe bending flexibility of the catheter shaft 710.

The distal end of the catheter shaft 710 can comprise a catheter tip716. In some embodiments, the catheter tip 716 can be located at themost distant portion of the distal end 702. The catheter tip 716 candefine at least a part of a catheter sheath 718 that is retractablerelative to the valve 500 so the valve 500 can be deployed or implantedfrom the catheter shaft 710 into the body.

In some embodiments, at least a portion of the catheter sheath 718comprises a clear or translucent material. With reference to FIG. 29A avisualization window 801 into cavity 714 may be provided in certainembodiments to permit an operator to verify that a device (such as valve500) has been loaded or inserted into the distal end 702 of thedeployment catheter. This visualization window 801 may be constructed ofa material that is at least translucent, but preferably transparent.

The catheter sheath 718 and/or catheter tip 716 can comprise a valveline (in certain embodiments, the valve line comprises a marker embeddedin or applied to the catheter sheath 718 to verify the proper placementof the valve 500. In a preferred embodiment, the valve line indicateswhere the valve 500 will deploy in the body. For example, one or morelocator markings (e.g., lines 802, 803) may be provided on the distalend 702, permitting an operator to visualize where a device will bedeployed. These locator markings 802, 803 may comprise a thinyellow-pigmented line 803 embedded in the catheter sheath 718 denotingthe approximate location where a device (such as the valve 500) will bedeployed. Further, the line 803 may be surrounded by widerblack-pigmented bands 802 to provide additional contrast for ease ofvisualization by the operator, for example through a bronchoscope. Someembodiments may have coils or other structural elements present at thedistal end. Accordingly, the lines 802 may then be useful to mask orhide such underlying structural elements to avoid confusing an operatoras to the location of the line 803. In certain embodiments, a valve 500may have one or more lines 802 or 803 disposed or printed directly uponit. Although the line 803 may be colored with different pigments, ayellow pigment was found to be easily visible through the visualizationchannel of a bronchoscope. Any method may be employed to place theselocator markings on the distal end 702. For example, pad printing orinkjet printing may be used to mark the lines 802 and 803 on the distalend 702. Other practices may be used to mark lines 802 and 803,including hot stamping, swaging, or reflowing a marker band. Lines 802could also be printed second on each side of the first printed line 803.Other configurations are possible, and of course, different pigments andlocator markings may be employed.

With reference to FIGS. 29C and 29D, a distal tip 770 of the catheter102 can include a marker line 772. The marker line 772 can beconstructed from a cross linked block polymer (e.g., Pebax®). In someembodiments, the marker line 772 is formed by extruding a portion ofmaterial (e.g., Pebax®) with predetermined inner and outer diameters.The portion of material can then be subjected to electronic beamradiation. Subjecting the marker line 772 material with electronic beamradiation can cross link the polymer chains in the marker line 772.Cross linking the polymer chains in the marker line 772 can reduce oreliminate the likelihood that the marker line 772 melts during a reflowprocess to form the distal portion of the catheter 102.

As illustrated, the cross linked marker line 772 can be positioned on amandrel 774. A bonding portion 776 of non-cross linked Pebax ® or othersuitable material can be positioned around the marker line 772. Thebonding portion 776 can be transparent or translucent to enable themarker line 772 to be visible after the reflow process. A heat shrinktube 778 (e.g., an FEP or Olefin tube) can be positioned around thebonding portion 776. When the distal tip 770 is subject to a reflowprocess, enhanced bonding between the bonding portion 776 and the markerline 772 can be achieved when both the bonding portion 776 and markerline 772 are constructed from a common material (e.g., Pebax®). Thecross linked material of the marker line 772 can retain its shape andthickness without melting when bonded with the bonding portion 776. Insome embodiments, the precision of the shape of the marker line 772(e.g., precision facilitated by a lack of melting) can enhance theprecision with which the user of the deployment catheter 102 canposition the medial device 500 within the distal tip 770 of the catheter102. The marker line 772 can have a gold color, a yellow color, or someother easily-visualized color. The bonding portion 776 and heat shrinktube 778 can be transparent or translucent to permit visualization ofthe marker line 772 from outside of the distal end 770 of the catheter102. Embedding the marker line 772 during the reflow process can help tostreamline the manufacturing process for the catheter 102 by decreasingor eliminating the need for a separate marker line application processin addition to reflow. As illustrated, embedding the marker line 772 canencapsulate the marker line 772 within the catheter 102 and can preventexposure of the marker line 772 to the patient.

With reference to FIG. 30, the catheter tip 716 preferably comprises ametal tip (e.g., titanium, nitinol) and/or plastic tip (e.g., PEBAX®,ISOPLAST™ or other urethanes, PEEK, polyetherimide, polyphenylenesulfide) or other suitably rigid structure that will allow the grippawls 228A, 228B to grip the deployment catheter 102 during loading. Aninsertion rod 760 may also be provided to push valve 500 past cathetertip 716 and into the cavity 714. In certain embodiments, the plasticand/or metal tip 716 is bonded to, adhered to, and/or embedded in thedistal end of the deployment catheter 102. The catheter tip 716preferably is manufactured such that compression forces or other forces,such as those encountered during loading and deployment of the catheter,do not cause appreciable deformation of the distal catheter tip. Incertain embodiments, the insertion rod 760 may also comprise alow-friction material, such as PTFE coating. Such a coating, may, forexample, be added on by means of a heat-shrink tubing. Coating theinsertion rod 760 or manufacturing it from a low-friction material mayprevent the valve 500 from being dragged out when the insertion rod 760is withdrawn.

Referring to FIG. 29B, certain embodiments may have the catheter tip 716located within a catheter sheath 718. In further embodiments, thecatheter tip 716 can be configured to contain the anchors 502 of themedical device 500, thereby keeping the device 500 compressed within thecavity 714. The catheter tip 716 also reduces the likelihood of thedevice 500 (especially anchors 502) scoring the inside of the cathetercavity 714 (which may create undesirable shavings) and snagging insidethe deployment catheter. Moreover, in use, some embodiments of thedeployment catheter 102 are capable of multiple deployments and,therefore, the tip 716 provides an enhanced lifespan for the deploymentcatheter 102. Certain embodiments may also have a tip 716 with avisualization window 801 cut through it. In further embodiments, the tip716 may have struts cut into it, providing additional flexibility to thecatheter 102 when being maneuvered through a tight turn.

In certain embodiments, an inner surface of the tip 718 can be coatedwith a polyurethane anti-block coating to reduce friction during valveloading and deployment. In some embodiments, the inner surface of thetip 716 or the deployment catheter 102 has no coating. Instead, theinner surface of the tip 716 or the deployment catheter 102 may comprisea polytetrafluoroethylene (PTFE) liner on a portion of the end of thedeployment catheter 102 and/or on the inner surface of the tip 718and/or the tip 716 to reduce the friction between the deploymentcatheter 102 and the valve 500, including but not limited to anymembrane material on the valve 500. In certain embodiments, the PTFEliner can be a more robust coating (e.g., a reduced wear coating).

In certain embodiments, the PTFE liner can be smooth on the innerdiameter of the deployment catheter 102, which contacts the valve 500,and can be chemically etched on the outer diameter of the deploymentcatheter 102 to provide a rough surface for better adhesion with anouter extrusion. The PTFE liner can be very thin (e.g., approximately0.001 inch to 0.002 inch in wall thickness). In certain embodiments, theliner can be then reflowed onto the outer extrusion of the catheterusing a heat process and a sacrificial extrusion (e.g., fluorinatedethylene-propylene (FEP) or Olefin) on the outside of the outer catheterextrusion. The process can concurrently apply heat to adhere the linerto the extrusion while the sacrificial extrusion (FEP or Olefin)compresses in diameter providing force to melt the two materialstogether.

In certain embodiments, the deployment catheter 102 can comprise adeployment guide on the exterior of the deployment catheter. Thedeployment guide can be positioned or embedded at the distal end of thedeployment catheter 102. The deployment guide can comprise a radiopaquematerial that is visible through the patient and/or the bronchoscope.The visible nature of the deployment guide allows the user to correctlyposition the valve at the target location.

With reference to FIG. 25, the proximal end of the catheter shaft cavity714 contains a tip 720 for a stabilization wire 722. The stabilizationwire tip 720 preferably is connected or coupled to a stabilization wire722 such that the two components move together in an axial directionrelative to the catheter shaft 710. The tip 720 can have any suitableconfiguration but preferably comprises a recess 724 in the distal end.The recess 724 can be used to enhance control over the valve 500 duringdeployment.

The stabilization wire 722 extends through the lumen 712 or passagewayin the catheter shaft 710. As discussed above, the lumen 712 of thecatheter shaft 710 can be coated to allow the stabilization wire 724 tomove more easily within the catheter shaft 710. For example, suchcoatings may include a PTFE liner embedded in lumen 712; such a linermay be added using any means available, such as a reflow process.Depending on the composition of the catheter shaft and/or the coating ofthe stabilization wire, no coating or PTFE liner may be needed. Thestabilization wire 722 will move axially relative to the catheter shaft710. More particularly, in some embodiments the stabilization wire 722is held stationary while the catheter shaft 710 is retracted proximally.Thus, the stabilization wire 722 can be slideable within, moved throughor advanced within the catheter shaft 710. The stabilization wire 722can be a Teflon coated stainless steel coil over a stainless steel wireto allow the catheter shaft 710 to easily traverse the bronchoscope orbody passageway.

In some embodiments, at the proximal end of the catheter shaft 710,there can be a reinforced shaft portion comprising a PTFE liner on theinterior of the catheter shaft 710. The liner at the proximal end of thecatheter shaft 710 preferably is generally thicker than at the distalend of the catheter shaft 710. The thicker liner improves pushabilitybut decreases the bendability of the reinforced portions thus thethinner liner at the distal end enables the catheter shaft 710 to turntighter radiuses than the proximal end.

In certain embodiments, the proximal end of the catheter shaft 710comprises a braid that is laid between the PTFE liner and the polymerextrusion comprising, for example, PEBAX® or nylon. In some embodiments,the braid provides resistances to stretching, buckling, and/or kinkingwhile delivering the valve or medical device 500 to the desiredlocation. The braid preferably is located closer to the inside diameterto reduce stiffness thereby increasing flexibility of the catheter shaft710. The braid can comprise a polymer (e.g., nylon, which can be clearand used for MRI applications), flat wire (e.g., 0.001 inch by 0.005inch), or other like materials. In certain embodiments, the braidcomprises a 60 pixs/inch configuration, wherein pixs refer to the numberof open spaces in one inch.

With reference to FIG. 26 and FIG. 27, the stabilization wire 722, whichis connected at its distal end to the stabilization wire tip 724,extends proximally to a cap 726 of control portion 704. To betterillustrate this, the stabilization wire 722 has been identified at boththe proximal end of the control portion 704 (i.e., at the cap 726) andat the distal end of the control portion 704. The proximal end of thestabilization wire 722 can be connected to the cap 726 in any suitablemanner. In some instances, the stabilization wire 722 and the cap 726are press fit, glued, adhered, cohered, comolded or the like.

At its proximal end, the stabilization wire 722 extends through atelescoping hypotube 728. The hypotube 728 encloses a portion of thestabilization wire 722. Thus, the hypotube 728 can provide lateralsupport to the stabilization wire 722 and can assist is reducing thelikelihood of the stabilization wire 722 buckling, bending or overlydeforming in the region of the hypotube 728. The hypotube 728 preferablyconnects to the cap 726 at a proximal end and abuts upon a proximal endof a sheath holder 730 at its distal end.

The distal end of the hypotube 728 nests within the sheath holder 730.Preferably, the hypotube 728 is axially moveable within the sheathholder 730. Thus, in this manner, the hypotube 728 is telescopingrelative to the sheath holder 730. The sheath holder 730 extendsdistally of the hypotube 728 and extends over a proximal end of thecatheter shaft 710. Preferably, the proximal end of the catheter shaft710 extends into the central portion of the sheath holder 730. Morepreferably, the catheter shaft 710 and the sheath holder 730 are joinedtogether for axial movement. Any suitable connection can be used.

A proximal end of a sleeve slider housing 732 snaps into the cap 726while the distal portion of the sleeve slider housing 732 encloses thesheath holder 730. Other connections also can be used to join the sleeveslider housing 732 and the cap 726. The snap fit, however, simplifiesconstruction and manufacturing.

The distal end of the sleeve slider housing 732 tapers toward theproximal portion of the catheter shaft 710. The sleeve slider housing732 allows relative axial movement to occur between the sheath holder730 and the sleeve slider housing 732. In other words, the sleeve sliderhousing 732 is designed to allow the sheath holder 730 to slideproximally relative to the sleeve slider housing 732 during deploymentof the valve 500. The relative proximal movement results in relativemovement between the catheter shaft 710, which is connected to thesheath holder 730, and the stabilization wire 722, which is connected tothe sleeve slider housing 732 through the mutual connection to the cap726.

Preferably, the sleeve slider housing 732 comprises an enlarged slot orwindow 734. As shown in FIG. 28, the slot or window 734 accommodates twofingers 736 of the sheath holder 730. The fingers 736 engage with slots738 formed in a sleeve slider 740. The sleeve slider 740, therefore, isjoined for axial movement with the sheath holder 730 and, through thesheath holder 730, to the catheter shaft 710. Thus, anyproximally-directed axial movement of the sleeve slider 740 will causecorresponding proximally-directed axial movement of the catheter shaft710 relative to the sleeve slider housing 732 and the attachedstabilization wire 722. In other words, movement of the outer sleeveslider 740 relative to the cap 726 and sleeve slider housing 732 willresult in movement of the catheter shaft 710 relative to thestabilization wire 722.

As illustrated in FIG. 27A, one or more frictional members 707 can bepositioned radially between the slider housing 732 and the sleeve sliderportion 740. The frictional member 707 could be a collar formed from ahigh friction material (e.g., rubber) and can be configured to increasethe sliding friction between the sleeve slider portion 740 and theslider housing 732. Increasing the sliding friction between the sleeveslider portion 740 and the slider housing 732 can reduce or eliminatethe likelihood that the user of the catheter 102 will inadvertentlydeploy the valve 500 from the distal end of the catheter 102 byaccidently sliding the sleeve slider portion 740 with respect to theslider housing 732 upon removal of a locking feature 746, as discussedbelow. The frictional member 707 can be configured to increase thesliding friction between the slider housing 732 and the sleeve sliderportion 740 to a greater extent in one sliding direction (e.g., thedirection of sliding where the catheter shaft 710 is withdrawn from thestabilization wire 722 to deploy the valve 500) than in the othersliding direction. For example, the frictional member 707 can be afrustoconical-shaped member constructed from rubber or other suitablehigh friction material(s).

The control portion 704 of the catheter 102 can include a biasing member709 (e.g., a coil spring, resilient tube) configured to engage with aseat 709 a on the sleeve slider portion and with a seat 709 b on theslider housing 732. The biasing member 709 can help to return thecatheter shaft 710 to a non-deployment position (e.g., a positionextended past the distal end of the stabilization wire 722) upon releaseof the sleeve slider portion 740 by the user of the catheter 102.

As illustrated in FIG. 27B, a frictional sleeve 707 a can be fixedaround at least a portion of the stabilization wire 722. The frictionalsleeve 707 a can be constructed of a flexible or semi-flexible material(e.g., silicone, rubber, polymer). In some embodiments, the frictionalsleeve 707 a is housed within a friction cavity 741 of the sleeve slider740. The frictional sleeve 707 a can be fixed in position with respectto sleeve slider 740 in the distal and/or proximal directions. Forexample, one or more flanges, crimp tubes, or other restrictionstructures within the friction cavity 741 can limit or prevent movementof the sleeve slider 740 in the proximal and/or distal directions withrespect to the sleeve slider 740. The frictional sleeve 707 a can beconfigured to frictional resist movement of the stabilization wire 722in the distal and/or proximal directions with respect to the sleeveslider 740. For example, an inner diameter of the frictional sleeve 707a can be smaller than an outer diameter of the stabilization wire 722.The frictional sleeve 707 a can stretch around the outer diameter of thestabilization wire 722 to provide a snug and/or high-friction fitbetween the inner diameter of the frictional sleeve 707 a and thestabilization wire 722.

A strain relief tube 742 can enclose at least a proximal portion of thecatheter shaft 710. The strain relief tube 742 can extend distally fromthe control portion 704 to a location somewhat proximal of the distalend of the catheter shaft 710. In some configurations, the strain relieftube 742 extends between the catheter shaft 710 and the passage in thesleeve slider housing 732, relative to which the catheter shaft 710moves. Thus, the catheter shaft 710, in some configurations, is capableof axial movement relative to the strain relief tube 742. Any suitablematerial can form the strain relief tube 742. In some embodiments, thestrain relief tube 742 may be made from a lubricious material such asPTFE. Some embodiments may also have an outer layer made of PEBAX®.

With reference to FIG. 31A, a view of the strain relief tube 742 ispresented. In certain embodiments, this strain relief tube extends overat least a portion of the catheter shaft 710, and is dimensioned to fitwithin the space between the outer surface of the catheter 710 and theinner surface of a bronchoscope (not shown). The strain relief tube 742minimizes clearance between the outer diameter of the catheter shaft 710and the inner lumen diameter of a bronchoscope working channel that thecatheter is inserted into (although other types of endoscopes may beused). By minimizing clearance, more accurate positioning of a device tobe delivered with the deployment catheter is possible. The clearancebetween the inner lumen diameter of the working channel and the outerdiameter of the strain relief tube 742 can be as small as possible whilestill permitting insertion into and axial movement within thebronchoscope working channel. In certain embodiments, the clearancebetween the bronchoscope inner lumen diameter and the strain relief tube742 outer diameter may be as low as about 0.5%, although values of about3% still permit relatively accurate device delivery. Similarly, and asdepicted in FIG. 31A, the clearance between the outer diameter ofcatheter 710 and the inner diameter of strain relief tube 742 can beminimized in consideration of the factors discussed above. In certainembodiments, the clearance between these two diameters may be as low asabout 1.8%, although values of about 5.1% still permit relativelyaccurate device delivery. While the strain relief tube 742 does notusually extend over the distal tip 702, minimization of clearancesbetween the distal tip and the inner lumen of a bronchoscope workingchannel helps to maintain placement accuracy of the device beingdelivered through the catheter. In certain embodiments, the clearancebetween the distal tip 702 and the bronchoscope working channel innerlumen diameter may be as low as about 0.7%, although values of about2.5% still permit relatively accurate device delivery. The clearancebetween the outer diameter of stabilization wire 722 and the innerdiameter of catheter 710 may also be minimized in consideration of thefactors discussed above. In certain embodiments, the clearance betweenthese two diameters may be as low as about 4.2%, although values of11.3% still permit relatively accurate device delivery.

Holes 821 may also be provided through the strain relief tube 742 and/orthe catheter shaft 710. In some embodiments, these holes may be usedduring sterilization procedures, for example sterilization proceduresemploying sterilization fluids, including gases such as ethylene oxide.These holes permit a sterilizing gas to pass into the body of thecatheter and other interstitial spaces. In certain embodiments, thediameter of the holes 821 may be tailored to effectuate an appropriatepressure difference between the interstitial spaces present in thecatheter 102 and the flow rate of sterilizing gas. In certainembodiments, the holes 821 only extend to the center of the strainrelief tube 742 and/or the catheter shaft 710, without passingcompletely through the strain relief tube 742 and/or the catheter shaft710. Preferably, the holes 821 in the catheter shaft 710 and the holes821 in the strain relief tube 742 are staggered, thus ensuring thatsterilizing gas may pass through a larger area of the interstitial spacebetween the strain relief tube 742 and the catheter shaft 710. Incertain embodiments, the diameter of the holes 821 in the catheter shaft710 are preferably 0.01″, although holes 821 measuring from 0.008″ to0.012″ were found to function acceptably. In certain embodiments, thediameter of the holes 821 in the strain relief tube 742 are preferably0.020″, although holes 821 measuring from 0.018″ to 0.025″ were found tofunction acceptably. In an embodiment of a catheter adapted to fit in a2.0 mm bronchoscope with holes measuring 0.01″, the flow rate wasmeasured to be 0.03 SLPM with 6 psi of pressure difference of nitrogengas, and 0.06 SLPM with 10 psi of pressure difference. This flow ratecompares favorably to the same catheter with no holes, where nomeasurable flow rate was found with up to 20 psi of pressure difference.Some embodiments may not require holes 821 if the flow rate is adequateto ensure acceptable sterilization. A catheter adapted to fit in a 2.6mm bronchoscope was measured to have a flow rate of 0.04 SLPM at 6 psiof pressure difference, and 0.09 SLPM at 10 psi of pressure differencewhile having no holes. A person of ordinary skill in the art willoptimize the hole diameter depending upon the particular catheter sizeand sterilization protocol used to achieve a sufficient flow rate ofsterilizing fluid.

FIGS. 31B-D depict cross sections taken along various parts of thecatheter 102 depicted in FIG. 31A. The apparent size of the crosssections may not be to scale. FIG. 31B depicts a cross section throughthe strain relief tube 742, the catheter shaft 710, and thestabilization wire 722. In certain embodiments, the catheter 710 may becomposed of a first layer 822, which can consist of a lubriciousmaterial such as PTFE. In certain embodiments, this first layer 822 mayhave a thickness of 0.001″. A braid 823 is then overlaid over the layer822, and a third layer 824, which can consist of PEBAX® or othermaterial with similar properties is overlaid. In certain embodiments,the braid 823 may be composed of stainless steel wire. The braid 823 mayalso have a thickness of 0.001″. In certain embodiments, the layer 824may have a thickness of 0.014″. This assembly is heated, causingsoftening or at least partial melting of the layer 824 into the braid823. The braid 823 is typically formed of a flexible material which doesnot deform substantially when stretched; it may be formed from asuitable metal such as stainless steel, for example but withoutlimitation. The braid 823 serves to prevent stretching and kinking ofthe catheter 710, while increasing flexibility. An optional fourth layer825 may also be added either before the heating step or subsequently.This fourth layer 825 may consist of fluorinated ethylene propylene(FEP), or any suitable material. This fourth layer 825 may belubricious, and may be added to the assembled catheter 710 by means ofheat-shrink tubing.

FIG. 31C shows a cross-section of the catheter 710 near the distal end702. Here, the stabilization wire tip 720 which contacts a medicaldevice inserted into the catheter cavity 714 is now visible. The strainrelief tube 742 is not typically disposed over the distal end 702, andas such, is not illustrated here. Near the distal end 702, the catheter710 may be composed of a first layer 822, usually of the samecomposition as described above. In certain embodiments, coils 826 may beprovided instead of a braid 823, and these coils 826 may then beoverlaid over the layer 822. Coils 826 provide additional resistance tokinking of the catheter when manipulated during operation. Duringmanufacturing, the portion of the catheter 710 with coils 826 may beoverlaid partially with the more proximal portion of the catheter 710with braids 823. A third layer 824, which can which can consist ofPEBAX® or other material with similar properties, may be overlaid on topof the coils 826. This assembly may then be heated, causing softening orat least partial melting of the layer 824 into the coils 826. A fourthlayer 825, described above, is optionally present. The third layer andfourth layers 824 and 825 are optionally constructed of a differentmaterial nearer the distal end than what is used at the proximal end.For example, the layer 824 may be constructed of a material that is atleast partially transparent, so as to form a visualization window 801.Other possibilities, such as modifying material thicknesses or otherphysical parameters, are also possible.

FIG. 31D shows a cross section of catheter 710 at the most distal end,through tip 716. Valve 500 is positioned within cavity 714, and iscontained by tip 716. Preferably, the extreme distal end of the tip 716extends beyond the valve 500 and forms an atraumatic tip structure.Outer sheath 718 is usually composed of the same material as the thirdlayer 824 or the optional fourth layer 825. Tip 716 may be bonded tosheath 718 by any means, including gluing or melting of the layer 718around tip 716. To provide a simplified structure resulting in thevisualization window 801 described above, the tip 716 can be spaced fromand not directly connected with the coils 826. Thus, the tip 716 may bejoined to the coils 826 with the outer sheath 718, which may beconstructed from polymeric materials such as PEBAX®, for example.

FIGS. 33A-E show various embodiments of the stabilization wire tip 720.In certain embodiments, the stabilization wire tip 720 may be of atwo-part construction comprising a cone 901 and a sleeve 900, as shownin FIG. 33A. The cone 901 is inserted over the stabilization wire 722.The cone 901 may be constructed from a rigid material, including metaland/or plastic. A sleeve 900 may be affixed to the cone 901. There mayalso be provided a cavity 902 capable of accepting at least part of amedical device, such as a valve 500. In certain embodiments, the sleeve900 may extend to the tip of the cup portion of a valve 500. In apreferred embodiment, the sleeve 900 extends past the tip of the cupportion of a valve 500 to its apex. FIG. 33C depicts an embodiment ofthe stabilization wire tip 720 manufactured as a single piece, with thecone 901 also possessing a sleeve capable of receiving at least part ofa medical device, such as a valve 500. FIG. 33B shows a stabilizationwire tip 720 possessing a cavity 903 with a flat end. The cavity 903with a flat end is not necessarily limited to two-part stabilizationwire tip embodiments of the type depicted in FIG. 33B. A cavity 903 witha flat end may also be provided with a one-piece stabilization wire tipdesign of the type depicted in FIG. 33C. Depending on the medical deviceaccepted into the cavity 903, such a flat end may prevent such a medicaldevice from snagging or becoming stuck within the cavity when deployed.Of course, cavities with different ends, such as those shown in theother illustrations are possible. In some embodiments, the ends of thecavities may be conical (for example the cavities 902, 904, 905). FIGS.33C-D also depict non-limiting embodiments of the stabilization wire tip720 possessing chamfered or beveled edges at the entrance of the cavity903. Such edges may aid in preventing the stabilization wire tip 720from snagging or catching on various internal portions of the catheter710, including the catheter sheath 718 or the distal tip 716, as well asany device inserted into it, such as a valve 500.

Also, and as shown in FIG. 33E, sleeve 900 may comprise locator markings802 and 803 disposed upon it. With reference to FIG. 33D, certainembodiments may provide a recess 905, which may for example be machinedout or molded from the cone tip 901. Such a recess 906 may be used toplace one or more locator markings 802 and/or 803 onto the cone tip 901,for example by means of a heat shrink tubing. In some embodiments, therecess 906 may also be widened to permit placement of one or more widerlocator markings. In embodiments of the stabilization wire tip 720possessing lines 802 and/or 803, the catheter sheath 718 is translucentor preferably transparent on at least the portion of the sheath 718 thatlies above the stabilization wire tip 720, such that an operator mayvisualize these lines. In a preferred embodiment, the sleeve 900 extendsto the apex of a valve 500, and has at least one marking (e.g., line803) disposed near this apex

Referring to FIG. 28, the control portion 704 can be constructed ofplastic, metal, or other suitable materials. Preferably, the sleeveslider 740 is a plastic molded piece. Accordingly, formation of ribs 744that define finger holds can be relatively cost effective and simple.Other configurations also are possible.

As explained above, movement of the sleeve slider 740 toward to the cap726 can cause deployment movement through retracting the catheter shaft710 relative to the stabilization wire tip 720, which pushes the valve500 out of the catheter tip 716 of the catheter shaft 710. Thus, in someembodiments, a locking feature 746 is desired that can reduce oreliminate the likelihood of inadvertent deployment of the valve 500 fromthe catheter tip 716.

The illustrated locking feature 746 comprises at least one member thatextends between the cap 726 and the sleeve slider 740. By extendingbetween at least these two components, the locking feature 746 canreduce the likelihood of inadvertent relative movement between thecatheter shaft 710 and the stabilization wire tip 720. Of course, it ispossible to configure another locking feature between the catheter shaft710 and the stabilization wire tip 720 in other manners by connectingeither directly or indirectly to the catheter shaft 710 and thestabilization wire.

With reference to FIG. 26, the locking feature 746 comprises a yokeshaped lock lever 748. The lever 748 comprises two legs 750 that connecttogether at a partial collar 752. The legs 750 each have a peg 754 thatsnaps into an opening in the sleeve slider 740. The pegs 754 can pivotrelative to the sleeve slider 740 such that the legs 750, and thereforethe lever 748 as a whole, can pivot relative to the sleeve slider 740.

As discussed above, the lever 748 comprises the partial collar 752. Thepartial collar can extend about half way around a lower portion of thecap 726. The degree to which the cap 726 is encircled can vary dependingupon the application but the partial collar 752 preferably extendsslightly more than 180 degrees around the cap 726. Other configurationsare possible.

The legs 750 are bowed in a direction opposite of the partial collar752. The bowing of the legs 750 enables easy manipulation with a singlehand by a user. In other words, the bowed legs 750 create a pair ofmanipulating locations 754, which are further enhanced with large pads,to facilitate easy disengagement of the collar 752 from the cap 726.Once the collar 752 is disengaged from the cap 726, the lever 748 can bemoved out of the way and the sleeve slider 740 can be pulled upwardtoward the cap 726 such that the valve 500 can be deployed. Withreference again to FIG. 1, the shipping lock 114 is a generallycylindrical tube in certain embodiments, and can comprise an internallumen. The shipping lock 114 can generally comprise a similar shape anddimension to that of the catheter shaft 710 of the deployment catheter102. The shipping lock 114 can be configured to be positioned into thesecond open cavity 218 of the housing structure 202 when the valveloader 106 is being shipped or stored for future use. In one embodiment,the shipping lock 114 can be inserted into the second open cavity 214 ofthe housing structure 202 and into the alignment tube 226, wherein thealignment tube 226 grips and/or locks the shipping lock 114 into thealignment tube 226 in a manner similar to the way the deploymentcatheter 102 can be locked in the alignment tube 226.

In certain embodiments, the loader plunger 220 can be positioned orpushed into the housing structure 202, and through the first open cavity214 of the housing structure 202, and into the inner lumen of theshipping lock 114. With the distal end of the loader plunger 220telescoped, nested and/or positioned in the inner lumen of the shippinglock 126, the loader plunger 220 can be generally stabilized duringshipping and storage, and the loader plunger 220 can be generallyprevented from vibrating or moving laterally or otherwise within thealignment tube 226 during shipping and/or storage. With the loaderplunger 220 substantially positioned within the housing structure 202,the loader plunger 220 is protected from breakage during shipping andstorage of the valve loader 106. By inserting the shipping lock 114 intothe alignment tube 226, the grip pawls 228A, 228B are put under tension,stress, and/or strain, which substantially prevents the leaf spring 306from becoming disengaged or decoupled from the first grip pawl 228A. Inremoving the shipping lock 114, the grip pawls 228A, 228B advantageouslyreturn to their default position and can be configured to receive thedeployment catheter 102.

In certain embodiments, the valve loading system 100 is a kit forstorage, transport, and/or loading that comprises a deployment catheter102, at least one cartridge 104 that comprises a valve 500, and a valveloader 106. In certain embodiments, the cartridges 104 are individuallypackaged sterilized cartridges 104 for single use and/or to bedisposable. In certain embodiments, the kit and/or components aretreated with ethylene oxide to make sterile for single patient use or tobe disposable. In certain embodiments, the cartridge, the valve loader,the kit and/or other components are configured to be sterilized ortreated for multiple use.

Methods of Use

A method of using the valve loading system 100 may be described inconnection with the figures. However, it will be appreciated that thevarious surgical procedures (for example, lung valve implantationprocedures, stent implantation procedures, or the like) that may use thevalve loading system 100 may vary from one procedure to the next,depending on the specific purpose and/or technique of the procedure.Accordingly the following description is intended to be generallyillustrative only and not limiting as to the present method.

As noted above, a user obtains the valve loading system 100. In someconfigurations, the valve loading system 100 can be obtained from asterile single patient use kit that comprises, among other things, adeployment catheter 102, at least one cartridge 104 that comprises avalve 500, and a valve loader 106. The user may slide or move the safetyslide mechanism 326 toward the distal end of the housing structure 202to unlock or allow the button 314 to be depressed into the housingstructure 202. By depressing the button 314 into the housing structure202, the shipping lock 114 can be unlocked and the user can remove theshipping lock 126 from the second open cavity 218. After removing theshipping lock 114, the user may release the button 314 and the safetyslide mechanism 326. In some configurations, simply depressing thebutton 314 causes the shipping lock 114 to be released and, therefore,the button 314 can be released before the shipping lock 114 is removed.The distal end of the deployment catheter 102 then can be inserted intothe second open cavity 218. The user can insert the deployment catheter102 into the second open cavity 218 until the user hears a click soundor other audible sound, which indicates to the user that the deploymentcatheter 102 has been locked into the housing structure 202 and has beenproperly positioned within the alignment tube 226. In certainembodiments, the visualization window 801 is provided at the distal tipof the catheter, permitting visual confirmation that a medical device(e.g., valve 500) is properly loaded into the distal tip of thedeployment catheter 102.

In certain embodiments, the user may retract, slide back, or move theloader plunger 220 from within the housing structure 202, thereby movingthe arm, bracket, or bar of the second end 250 of the cartridge lockingmechanism 222 from the first open cavity 214. The user may select adesired cartridge 104 containing the appropriate size, shape, and/ortype valve or medical device 500. In certain embodiments, the user mayproper align the cartridge 104 with the first open cavity 214 in orderto insert the cartridge 104 into the first open cavity 214. After thecartridge 104 has been fully inserted into the first open cavity 214,the user may push, slide, or move the loader plunger 220 into thehousing structure 202, thereby allowing a bayonet end of the loaderplunger 220 to contact the valve or medical device 500 within thecartridge 104.

As the plunger 220 contacts and pushes the valve or medical device 500toward the distal end of the cartridge 104 and through the tapered orfunnel portion of the cartridge 104, the valve or medical device 500becomes compressed. With the valve or medical device 500 compressed, theuser can continue to push the loader plunger 220 into the housingstructure 202, thereby pushing the compressed valve or medical device500 through the alignment insert 224 and the alignment tube 226, andinto the distal end of the deployment catheter 102. In some embodiments,the catheter shaft 102 can be manufactured to have a length resulting inan axial (e.g., in the direction parallel to the length of the catheter)gap between the inserted medical device 500 and the stabilization wire722. For example, a gap can be accounted for to reduce or eliminate thepossibility that the medical device 500 could be damaged duringinsertion into the catheter 102 if the medical device 500 were to beaxially compressed between the stabilization wire 722 and the plunger220 due to manufacturing tolerances wherein the catheter shaft 102 isshorter in length than the nominal design.

As described above, reinforcing the catheter shaft 102 with a metal orpolymer braid can reduce or eliminate variances in the axial lengthand/or diameter of the catheter shaft 102 during manufacturing. In someembodiments, reinforcing the shaft 102 with a metal or polymer braid canreduce or eliminate a potential need to manufacture an axial gap betweenthe desired loaded valve 500 position and the distal end of thestabilization wire 722. With the deployment catheter 102 loaded with thevalve or medical device 500, the user may slide or move the safety slidemechanism 326 toward the distal end of the housing structure 202, tounlock or allow the button 314 to be depressed into the housingstructure 202.

In depressing the button 314 into the housing structure 202, thedeployment catheter 102 can be unlocked, and the user can remove thedeployment catheter 102 from the second open cavity 218. In certainembodiments, the user can position the loaded deployment catheter 102into the body of the patient at the desired location in order to implantthe valve or medical device 500 in the patient. In certain embodiments,the deployment catheter 102 is advanced through a channel of abronchoscope. Advancement of the deployment catheter 102 through thechannel of the bronchoscope can result in axial (e.g., parallel to thelength of the catheter shaft 102) compression of the catheter shaft 102.Compression of the catheter shaft 102 can move the loaded medical 500device toward the stabilization wire 722. In some embodiments,manufacturing the catheter shaft 102 to have a length such that an axialgap is created between the medical device 500 and the stabilization wire722 can reduce or eliminate the risk that the medical device 500 bepartially or wholly inadvertently deployed from the distal end of thecatheter shaft 102 as the catheter shaft 102 is advanced through theworking channel of a bronchoscope. The axial gap between the distal tipof the stabilization wire 722 and the proximal end of the medical device500 can be reduced or eliminated by the user of the catheter 102 whenthe catheter 102 is positioned at a sight of interest within the body.For example, the user can withdraw the catheter 102 from thestabilization wire 722 until the user receives tactile, aural, and/orvisual feedback that the stabilization wire 722 is in contact with themedical device 500. Contact between the stabilization wire 722 and themedical device 500 can help to ensure that the medical device 500 isdeployed in the intended position in the body. In some embodiments,failing to reduce or eliminate an axial gap between the stabilizationwire 722 and the medical device 500 can result in a deployment of themedical device 500 to a position proximal from the position at whichdeployment was intended. For example, as the catheter sheath 710 iswithdrawn from (e.g., pulled proximally with respect to) thestabilization wire 722, the catheter sheath 710 can carry the medicaldevice 500 in the proximal direction until the medical device 500 comesinto contact with the stabilization wire 722. In some embodiments,proximal movement of the medical device 500 relative to thestabilization wire 722 can result in a medical device deploymentproximal of the intended deployment location. According to somevariants, the axial gap between the stabilization wire 722 and themedical device 500 can vary between catheter shafts 102. Variability inthe axial gap can make it desirable, in some embodiments, to reduce oreliminate the gap as described above prior to deployment of the medicaldevice 500.

In some embodiments, the catheter shaft 102 can be constructed (e.g.,the catheter shaft 102 can include reinforcing metal or polymer braids)such that any axial (e.g., parallel to the length of the catheter shaft102) compression of the catheter shaft 102 is reduced or eliminated asthe catheter shaft is advanced through the channel of the bronchoscope.In some embodiments, reinforcing the catheter shaft 102 with metal orpolymer braids can reduce or eliminate the likelihood that a variablemanufactured gap between the distal end of the stabilization wire 722and medical device 500 would be formed. For example, the reinforcementof the catheter shaft 102 can decrease the variance in lengths of thecatheter shafts 102 as they are manufactured. Decreasing the variance incatheter shaft 102 lengths can decrease the variance in gap sizesobtained during the medical valve loading process.

The catheter shaft 102 can be navigated to the target implant locationvia the bronchoscope. In certain embodiments, the valve or medicaldevice 500 (e.g., comprising radiopaque material) is visible through thedeployment catheter 102 to allow the user to correctly position thevalve at the target location. For example, in certain embodiments, theuser can use the deployment guide, which can comprise a radiopaquematerial that is visible through the body, to allow the user tocorrectly position the valve the target location.

To deploy the valve or medical device 500, the user, in certainembodiments, unlatches, turns, or swings the locking feature 746 todisengage the locking feature 746 from the cap 726. The user can actuatecontrol portion 704 to cause the catheter sheath 710 to retract relativeto the stabilization wire 722 to release the valve or medical device500. The position of the valve or medical device 500 is stabilized atthe target location during deployment with the stabilization wire 722.

In certain embodiments, after the valve or medical device 500 has beendeployed, the deployment catheter 102 can be retrieved from the body ofthe patient, and be reloaded with another valve or medical device 500using the foregoing process. With the foregoing process, the deploymentcatheter 102 can be reloaded with different valves or medical devices500 having different shapes, sizes, and/or types. The foregoing processalso allows the valve or medical device 500 to remain in a defaultconfiguration, as opposed to a substantially compressed or stressedconfiguration, thereby reducing the possible failure, wear, and/ordeterioration of the valve or medical device 500. In other words, thecartridge 104 stores the valve or medical device 500 in a non-compressedstate, which reduces wear and tear on the medical device 500 and reducesthe likelihood of an adverse clinical event relating to the materials orstructure of the medical device 500.

FIGS. 32 A-C shows an embodiment of catheter 201 with a valve 500 loadedwithin it. A deployment catheter 102 is inserted into a bronchoscope(not shown), and the bronchoscope is guided to a portion of a lungrequiring treatment. In determining an appropriate deployment site forthe valve 500 (here, denoted as deployment site 820), an operator mayuse the yellow line 803 to align the catheter with the site where thevalve will be deployed, as the valve 500 will be released from thedistal end of the catheter at the approximate location denoted by theyellow line. In some embodiments, the line 803 generally aligns with anair passageway region that the membrane of the valve 500 will seal. Theblack bands 802 provide additional contrast so that the operator caneasily see the line 803 through a bronchoscope viewing port. Moreover,an operator can extend the catheter distally beyond the visualization ofthe black bands and then retract the catheter proximally. Whileretracting the first black band 802 encountered can be used as alandmark indicating that the line 803 is approaching. With the line 803aligned with the deployment site 820, the operator depresses the plunger220 (shown in FIG. 1), thereby retracting catheter sheath 710 while thestabilization wire 722 remains generally stationary. The stabilizationwire tip 720 at the end of the stabilization wire 722 contacts thecentral rod 821 of valve 500 within recess 724, thereby maintainingvalve 500 in substantially the same position while the sheath 710 isretracted. Freed from the catheter, the anchors expand into contact withthe air passageway wall and the valve 500 expands so that the apex ofits cup portion makes contact with the lung walls generally at the site820 selected along the lung passageway wall.

Although this invention has been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that the present invention extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinvention and obvious modifications and equivalents thereof. Inaddition, while several variations of the invention have been shown anddescribed in detail, other modifications, which are within the scope ofthis invention, will be readily apparent to those of skill in the artbased upon this disclosure. It is also contemplated that variouscombinations or sub-combinations of the specific features and aspects ofthe embodiments may be made and still fall within the scope of theinvention. It should be understood that various features and aspects ofthe disclosed embodiments can be combined with, or substituted for, oneanother in order to form varying modes or embodiments of the disclosedinvention. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

What is claimed is:
 1. A method of manufacturing a catheter, the methodcomprising the steps of extruding an annular shaped valve marker, thevalve marker comprising a first material; subjecting the valve marker toelectric beam radiation or chemical cross linking through use ofperoxide to cross link the polymer chains of the first material in thevalve marker; overlaying the valve marker on a mandrel; overlaying anannular bonding layer around an outer surface of the valve marker,bonding layer comprising the first material; overlaying a heat shrinktube around an outer surface of the bonding layer; and reflowing thevalve marker, bonding layer, and heat shrink tube; wherein the bondinglayer and valve marker are bonded together and the valve marker is notmelted.
 2. The method of claim 1, wherein the valve marker has a gold oryellow color.
 3. The method of claim 1, wherein the bonding layer isconstructed from a translucent or transparent material.
 4. The method ofclaim 1, wherein the first material is a polymer.
 5. The method of claim1, wherein the first material is Pebax®.
 6. A deployment catheter fordeployment of a medical device, the deployment catheter comprising: acatheter shaft comprising a proximal end and a distal end and a lumenextending through the catheter shaft, the catheter shaft being formedfrom a braided material overlaid with a polymer; a first cavity inside adistal portion of the catheter shaft adapted to receive a medicaldevice, wherein the medical device is a valve; and a stabilization wireextending through the lumen of the catheter shaft, the stabilizationwire comprising a second cavity disposed at a distal end of thestabilization wire, the second cavity configured to receive at least aportion of the medical device, wherein the catheter shaft retractsrelative to the stabilization wire during deployment of the medicaldevice.
 7. The deployment catheter of claim 6, wherein the braidedmaterial is one or more of a metallic material and a polymer.
 8. Thedeployment catheter of claim 1, wherein the second cavity comprises anopen end and a closed end, wherein the closed end comprises a flatsurface that is perpendicular relative to side walls of the secondcavity.
 9. The deployment catheter of claim 1, wherein the second cavitycomprises an open end and a closed end, wherein the closed end comprisesa conical configuration.
 10. The deployment catheter of claim 1, whereinthe second cavity comprises an open end and a closed end, wherein theclosed end comprises a hemispherical configuration.
 11. The deploymentcatheter of claim 1, wherein the stabilization wire comprises a distalend that is chamfered.
 12. The deployment catheter of claim 1, furthercomprising a locator marking disposed on a side wall of the cathetershaft and along the distal portion of the catheter shaft, the locatormarking being viewable from an outside of the catheter shaft, and thelocator marking corresponding to an approximate deployment site of themedical device disposed within the catheter shaft.
 13. The deploymentcatheter of claim 12, wherein the locator marking is yellow.
 14. Thedeployment catheter of claim 12, wherein the locator marking comprises ayellow pigmented band with two black pigmented bands disposed adjacenton either side of the yellow pigmented band.
 15. The deployment catheterof claim 1, wherein the catheter shaft comprising at least one openingon a side wall of the catheter shaft.
 16. The deployment catheter ofclaim 15, wherein the at least one opening permits a sterilizing gas orfluids to pass into the lumen of the catheter shaft.
 17. The deploymentcatheter of claim 1, further comprising a rigid tip disposed at thedistal end of the first cavity inside the catheter shaft, the rigid tipable to accommodate at least a portion of the medical device loadedtherein.
 18. The deployment catheter of claim 17, wherein the rigid tipcomprises a material configured to reduce scoring of an inside surfaceof the rigid tip by anchors of the medical device.
 19. The deploymentcatheter of claim 17 further comprising an at least partiallytransparent segment disposed between the locator marking and the rigidtip, the at least partially transparent segment permitting visualizationof at least a portion of the first cavity near the distal end of thecatheter shaft.
 20. A deployment catheter comprising: a catheter shaftcomprising a proximal end and a distal end and a lumen extending throughthe catheter shaft; a stabilization wire disposed at least partiallywithin the catheter shaft; a proximal handle assembly, the proximalhandle assembly comprising a sleeve slider and a sleeve slider housingcoaxially arranged with the sleeve slider, the sleeve slider fixedlycoupled with the catheter shaft, the sleeve slider housing fixedlycoupled with the stabilization wire; and a frictional member disposedbetween the sleeve slider or stabilization wire and the sleeve sliderhousing to increase sliding friction between the sleeve slider orstabilization wire and the sleeve slider housing.
 21. The deploymentcatheter of claim 20, wherein the frictional member is configured toincrease sliding friction between the sleeve slider and the sleeveslider housing in one sliding direction relative to the sliding frictionbetween the sleeve slider and the sleeve slider housing in an oppositesliding direction.
 22. The deployment catheter of claim 20, furthercomprising a biasing member configured to bias the sleeve slider housingin the proximal direction with respect to the sleeve slider.